2011-27857. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Protease Deficient Bacillus anthracis With Improved Recombinant Protein Yield Capabilities

Description of Technology: Species of Bacillus, such as Bacillus anthracis, Bacillus cereus, and Bacillus subtilis, are attractive microorganisms for recombinant protein production in view of their fast growth rate, high yield, and ability to secrete produced products directly into the medium. Bacillus anthracis is also attractive in view of its ability to produce anthrax toxin and ability to fold proteins correctly. This application claims a B. anthracis strain in which more than one secreted protease is inactivated by genetic modification. Such a protease-deficient B. anthracis has an improved ability to produce recombinant secreted proteins compared to other bacteria, particularly other Bacillus. Improvements include production of intact (i.e., mature full-length) proteins, often at high yield.

Potential Commercial Applications:

• Vaccine production
• Recombinant protein production
• B. anthracis vaccine production

Competitive Advantages:

• Highly efficient production of recombinant proteins
• Low cost production of recombinant proteins

Development Stage:

• Early-stage
• In vitro data available

Inventors: Andrei Pomerantsev and Stephen Leppla (NIAID).

Publication: Pomerantsev A, et al. A Bacillus anthracis strain deleted for six proteases serves as an effective host for production of recombinant proteins. Protein Expr Purif. 2011 Nov;80(1):80-90. [PMID 21827967].

Intellectual Property:

• HHS Reference No. E-202-2011/0—U.S. Provisional Application No. 61/514,384 filed 02 Aug 2011
• HHS Reference No. E-202-2011/1—U.S. Provisional Application No. 61/521,617 filed 09 Aug 2011

Licensing Contact: Peter Soukas, J.D.; [phone]; [e-mail].

Collaborative Research Opportunity: The NIAID is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize B. anthracis vaccines, B. anthracis protein production. For collaboration opportunities, please contact Charles Rainwater at [phone].

Parvovirus B19 Codon Optimized Structural Proteins for Vaccine and Diagnostic Applications

Description of Technology: Parvovirus B19 (B19V) is the only known pathogenic human parvovirus. Infection by this viral pathogen can cause transient aplastic crisis in individuals with high red cell turnover, pure red cell aplasia in immunosuppressed patients, and hydrops fetalis during pregnancy. In children, B19V most commonly causes erythema infectiosum, or fifth's disease. Infection can also cause arthropathy and arthralgia. The virus is very erythrotropic, targeting human erythroid (red blood) progenitors found in the blood, bone marrow, and fetal liver. Currently, there are no approved vaccines or antiviral drugs for the treatment or prevention of B19V infection.

The subject technology is a series of plasmid constructs with codon optimized B19 viral capsid genes (VP1 and VP2) that can be expressed in mammalian cells. Transfection of vectors encoding these optimized VP1 and VP2 genes into different mammalian cell lines, including 293, Cos7, and HeLa cells produce virus-like particles (VLPs). The vectors include bicistronic plasmids expressing the VP1 and VP2 proteins at different ratios to produce B19V VLPs with optimal antigenicity for vaccine applications. This technology can also be used for diagnostic applications and development of a viral packaging system for producing infectious B19V virus.

Applications:

• VLPs based vaccines for the prevention and/or treatment of B19V infection
• DNA based vaccines for the prevention and/or treatment of B19V infection
• B19V diagnostics
• Viral packaging system

Advantages:

• Codon optimized VP1 and VP2 genes for better expression in mammalian cell lines
• Expression of B19V VLPs from “nonpermissive” cell lines

Development Stage: In vitro data available.

Inventors: Ning Zhi, Sachiko Kajigaya, and Neal S. Young (NHLBI).

Patent Status: HHS Reference No. E-011-2010/0—PCT Application No. PCT/US2011/024199 filed 09 Feb 2011.

Licensing Contact: Kevin W. Chang, Ph.D.; [phone]; [e-mail].

Collaborative Research Opportunity: The National Heart Lung and Blood Institute, Hematology Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the subject technology. Please contact Cecilia Pazman, Ph.D., at [e-mail] for more information.

Dated: October 21, 2011.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.